II 

118TH CONGRESS 

2D SESSION S. 5103 

To require the Secretary of Health and Human Services to develop a strategic 

plan for the Human Foods Program of the Food and Drug Administration and the food functions of the Office of Inspections and Investigations, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 19, 2024 

Mr. BUDD (for himself and Mr. MARKEY) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To require the Secretary of Health and Human Services 

to develop a strategic plan for the Human Foods Program of the Food and Drug Administration and the 

food functions of the Office of Inspections and Investigations, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Food and Drug Ad5 ministration Foods Accountability Act’’. 


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1 SEC. 2. FOOD AND DRUG ADMINISTRATION FOODS AC2 COUNTABILITY ACT. 

3 (a) FDA HUMAN FOODS PROGRAM STRATEGIC

4 PLAN.— 

5 (1) IN GENERAL.—Not later than September 

6 30, 2025, and at least every 4 years thereafter, the 

7 Secretary of Health and Human Services (referred 

8 to in this section as the ‘‘Secretary’’) shall develop 

9 and submit to the appropriate committees of Con10 gress and post on the website of the Food and Drug 

11 Administration a strategic plan for the Human 

12 Foods Program of the Food and Drug Administra13 tion and the food functions of the Office of Inspec14 tions and Investigations (or any successor programs 

15 of the Food and Drug Administration responsible for 

16 the regulation of human foods). 

17 (2) CONTENT OF STRATEGIC PLAN.—The stra18 tegic plan under paragraph (1) shall include— 

19 (A) strategic goals and priorities related 

20 to— 

21 (i) food safety, including implementa22 tion of the FDA Food Safety Moderniza23 tion Act (Public Law 111–353) and coordi24 nation and engagement across the Food 

25 and Drug Administration with Federal, 

26 State, local, and Tribal entities and private 


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1 sector entities, to improve food safety over2 sight; 

3 (ii) food safety inspections, including 

4 coordination and engagement across the 

5 Food and Drug Administration to meet in6 spection goals and coordination with Fed7 eral agencies, including the Centers for 

8 Disease Control and Prevention and the 

9 Department of Agriculture, and State, 

10 local, and Tribal entities to oversee food 

11 safety and conduct related inspections; 

12 (iii) administration of the Office of 

13 Critical Foods and related activities of the 

14 food functions of the Office of Inspections 

15 and Investigations and other offices or di16 visions of the Food and Drug Administra17 tion, including identification of any poten18 tial interruption in the supply of critical 

19 foods and what steps such Office would 

20 take in response, incorporating lessons 

21 from previous similar scenarios; 

22 (iv) initiatives to support nutritional 

23 health, including initiatives and activities 

24 of the Center for Excellence in Nutrition 

25 designated by the Secretary under the 


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1 Human Foods Program, evidence-based 

2 initiatives to address chronic diet-related 

3 diseases, and administration of food label4 ing requirements, engagement with the Di5 etary Guidelines Advisory Committee in 

6 years when the Committee is reviewing up7 dates to the Dietary Guidelines, and any 

8 other programs related to nutrition; 

9 (v) activities and programs to support 

10 recruiting, hiring, training, developing, and 

11 retaining a qualified workforce within the 

12 Human Foods Program and the food func13 tions of the Office of Inspections and In14 vestigations, including any cooperative pro15 grams with other entities to support re16 cruitment and training of food safety in17 spectors, and reviewers to support review 

18 of regulatory submissions for food prod19 ucts; 

20 (vi) in the first such plan, specific 

21 metrics and other information identifying 

22 improvements made as a result of the reor23 ganization of the Center for Food Safety 

24 and Applied Nutrition and establishment 

25 of the Human Foods Program and the 


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1 food functions of the Office of Inspections 

2 and Investigations, including how any full3 time equivalent positions within the Food 

4 and Drug Administration have been reallo5 cated under the reorganization, and bench6 marks against which to assess the perform7 ance of the Human Foods Program and 

8 the food functions of the Office of Inspec9 tions and Investigations; and 

10 (vii) other priorities identified by the 

11 Secretary; 

12 (B) specific activities and strategies for 

13 achieving the goals and priorities identified 

14 under subparagraph (A), and progress towards 

15 achieving such goals and priorities; 

16 (C) specific activities and strategies for im17 proving and streamlining internal coordination 

18 and communication within the Food and Drug 

19 Administration, including for activities and 

20 communications related to signals of potential 

21 public health concerns, as well as other agencies 

22 and offices of the Department of Health and 

23 Human Services and other Federal departments 

24 and agencies, as appropriate; 


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1 (D) specific activities and strategies for 

2 improving and streamlining coordination and 

3 communication with non-Federal stakeholders, 

4 including steps to improve outreach regarding 

5 rulemaking activities; and 

6 (E) challenges and risks the Human Foods 

7 Program is expected to face in meeting its stra8 tegic goals and priorities, and the activities the 

9 Human Foods Program will undertake to over10 come those challenges and mitigate those risks. 

11 (3) EVALUATION OF PROGRESS.—Not later 

12 than September 30, 2027, and every 2 years there13 after, the Secretary shall submit to the appropriate 

14 committees of Congress and post on the website of 

15 the Food and Drug Administration a progress report 

16 that includes— 

17 (A) a description of the progress the Sec18 retary has made toward the goals and priorities 

19 identified under paragraph (2)(A) in the most 

20 recent strategic report submitted under para21 graph (1); and 

22 (B) whether actions taken in response to 

23 the most recently submitted strategic plan im24 proved the capacity of the Food and Drug AdVerDate Sep 11 2014 00:22 Sep 20, 2024 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S5103.IS S5103

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1 ministration to achieve the strategic goals and 

2 priorities set forth in previous strategic plans. 

3 (4) UPDATES.—The Secretary shall, as appro4 priate, update the strategic plan to account for sig5 nificant changes in the production and regulation of 

6 foods or the scientific evidence related to nutrition 

7 and food production, or other significant changes, as 

8 the Secretary determines appropriate. 

9 (b) GAO REPORT.— 

10 (1) IN GENERAL.—Not later than September 

11 30, 2028, the Comptroller General of the United 

12 States shall submit to the Committee on Health, 

13 Education, Labor, and Pensions of the Senate and 

14 the Committee on Energy and Commerce of the 

15 House of Representatives a report assessing the ini16 tial strategic plan submitted under subsection (a). 

17 (2) CONTENTS OF REPORT.—The report re18 quired under paragraph (1) shall include an assess19 ment of— 

20 (A) the development and implementation of 

21 the strategic plan, including the sufficiency of 

22 the plan, progress of the Human Foods Pro23 gram in meeting the results-oriented goals and 

24 priorities identified in such plan, and any gaps 

25 in such implementation; 


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1 (B) how the Human Foods Program ap2 plies hiring authorities under section 714A of 

3 the Federal Food, Drug, and Cosmetic Act (21 

4 U.S.C. 379d–3a); and 

5 (C) recommendations for the Human 

6 Foods Program to address the identified chal7 lenges, improve its implementation of the 

8 Human Foods Program strategic plan, and to 

9 otherwise improve the public health mandate of 

10 the Food and Drug Administration. 

Æ 


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